Medical Career Leader

5 days ago

Allahabad, Uttar Pradesh, India beBeeProfessional Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

We are seeking an accomplished medical professional to spearhead our clinical and post-marketing drug safety teams.

Clinical Phase:
  • As a senior medical monitor, you will oversee study protocols, review and provide feedback as needed, and deliver therapeutic area training for our case processing team.
  • You will also be responsible for drafting medical monitoring plans, ensuring compliance, and reviewing adverse events reported by study sites.
  • Making assessments on SUSAR reportability and performing reviews and interpretations of clinical data are key responsibilities.

Post-Marketing (Pharmacovigilance):

  • You will support the maintenance of our medical platform, including SOPs, manuals, and documents.
  • Leading and supporting medical reviewers, interacting with clients' medical teams and clinical teams, and acting as a main point of contact for client concerns and escalations.
  • Your expertise will also be used to mentor junior medical reviewers, perform additional reviews of cases, and provide ongoing workshops and feedback.

Requirements:

  • An MBBS or MD degree is required.
  • A minimum of 10 years of experience working in service providers or pharmaceutical companies, with at least 5-7 years of experience as a Medical Monitor or in clinical phases.
  • Excellent technical skills, including Microsoft packages, strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety, and deep knowledge of pharmacovigilance principles and adverse event reporting.

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